XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study

Coronary Artery Disease Clinical Trial

— XIENCE V India  

Official title:

XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631228
• Other study ID #: 07-378
• Secondary ID: REFCTRI000213, 2
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2008
• Last updated: August 13, 2012
• Start date: June 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Central Drugs Standard Control Organization
• Study type: Observational

Clinical Trial Summary

XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Description:

Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.

Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Single-Arm Study (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval XIENCE V India study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the XIENCE V India study, from 5 years to after completion of the three year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

• The inability to obtain an informed consent is an exclusion criterion.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease

Locations

Country	Name	City	State
India	Krishna Heart Institute	Ahmedabad	Gujarat
India	SAL Hospital And Medical Institute	Ahmedabad
India	Escorts Heart & Superspeciality Institute Ltd.	Amritsar
India	Madras Medical Mission	Chennai
India	Lisie Heart Institute,Lisie Hosp.	Cochin
India	CARE Hospital	Hyderabaad	Andhra Pradesh
India	Apollo Hospital	Hyderabad
India	Krishna Heart Institute,	Hyderabad	Andhra Pradesh
India	Heart & General Hospital	Jaipur
India	Dayanand Medical College & Hospital	Ludhiana	Punjab
India	Holy Family Hospital	Mumbai
India	Escorts Heart Institute & Research Centre	New Delhi
India	Escorts Heart Institute & Research Centre	New Delhi
India	Fortis Hospital	New Delhi
India	Max Devki Devi Heart & Vascular Institute	New Delhi
India	Jehangir Hospital	Pune
India	Poona Hospital And Research Centre	Pune
India	Christian Medical Center (CMC)	Vellore	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent thrombosis rates as defined by Academic Research Consortium (ARC)		Annually through to 3 years	Yes
Primary	Composite endpoint of cardiac death and myocardial infarction (MI)		at 1 year	Yes
Secondary	Composite rate of cardiac death and any MI (Q-wave and non Q-wave)		at 30, 180 days and at 2 and 3 years	Yes
Secondary	Composite rate of all death and any MI (Q-wave and non Q-wave)		at 30, 180 days and at 2 and 3 years	Yes
Secondary	Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG)		at 30, 180 days and at 2 and 3 years	Yes
Secondary	Death (cardiac death, vascular death, and non-cardiovascular death)		at 30, 180 days and at 2 and 3 years	Yes
Secondary	Any MI (Q-wave and non Q-wave)		at 30, 180 days and at 2 and 3 years	Yes
Secondary	Major bleeding complications		at 14, 30, 180 days and at 1, 2 and 3 years	Yes
Secondary	Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy		at 14, 30, 180 days and at 1, 2 and 3 years	Yes
Secondary	Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)		at 30, 180 days and at 1, 2 and 3 years	Yes
Secondary	Clinical device and procedural success		Acute	Yes
Secondary	Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire		at baseline, 180 days, and 1 year	No
Secondary	Stent thrombosis		24 hours (acute) and 30 days (sub-acute)	Yes
Secondary	Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)		30, 180 days and 1, 2 and 3 years	Yes